WO2000045746A1

WO2000045746A1 - Injector for implanting a folded intraocular lens, container for storing and transporting the injector and method for ejecting the lens in a folded state

Info

Publication number: WO2000045746A1
Application number: PCT/DE2000/000262
Authority: WO
Inventors: Helmut Binder
Original assignee: Helmut Binder
Priority date: 1999-02-03
Filing date: 2000-02-01
Publication date: 2000-08-10
Also published as: US6607537B1; CA2360915C; DE50002585D1; EP1152714A1; ATE243008T1; AU2793900A; DE19904220C2; ES2203424T3; CA2360915A1; DE19904220A1; EP1152714B1

Abstract

The invention relates to an injector for implanting a folded intraocular lens. A folded lens can be introduced into the lens capsule of the eye through an approximately 3 mm long slit opening in the eye. The novel injector is characterised in that it consists of only three parts: a one-piece body (2), a swivel flap (3) which is provided with a folding rib (11) and which enables the lens (20) to be held in a first position above the transport channel in an unfolded state before being pressed in radially so as to slide into the transport channel in a folded state; and a third component, the slide (4), by which means the folded lens (20) can be slid forwards in a longitudinal direction and then ejected out of the injector into the eye.

Description

INJECTOR FOR IMPLANTING A FOLDED INTRAOCULAR LENS,

CONTAINER FOR STORING AND TRANSPORTING THE INJECTOR AND

METHOD FOR FOLDING THE LENS

DESCRIPTION

The invention relates to an injector for implanting a (temporarily) folded intraocular lens, with which the folded lens can be inserted into the lens capsule of the eye through an approx. 3 mm cut opening in the eye, according to the preamble of claim 1, a container for storage and Transporting the injector according to the preamble of claim 14 and to a method for folded deployment of the lens using the injector according to the preamble of claim 18.

In ophthalmic surgery, it is of great importance that the surgical incision through which the cataract is operated and then the required artificial lens is implanted is as small as possible (approx. 3 mm), so that an optimal healing process is guaranteed and no sutures are required. In order to be able to implant artificial lenses with the required diameter of approx. 5 - 6mm, they have to be foldable so that they fit through the small cut of 3mm.

A wide variety of devices are known for folding the lenses and inserting the folded lens with the aid of tweezers, and also injectors for inserting the lenses directly into the eyes. In the latter case, the essentially unfolded lens is generally folded in an axially progressive manner during advancement in the injector, or an already folded lens is inserted and only pushed out. So z. B. from EP 0 503 136 AI, EP 0 497 505 AI, EP 0 402 138 AI, WO 98/25548, WO 94/10912 and DE 40 39 119 Cl devices for folding an intraocular lens in various embodiments known by which Lenses are folded or pre-folded accordingly and then inserted into the eye using tweezers or an injector. This process is relatively complex and also unsafe due to handling with the tweezers, since the folded lens can easily slip out of the tweezers.

Lens injectors are known from DE 41 10 278 AI, DE 36 10 925 C2, WO 96/15743, EP 0 270 257 AI, EP 0 477 466 AI, WO 97/113 476, WO 97/15253 Part of the prefabricated lenses is inserted into the receiving chamber of an insertion cartridge that can be attached to the front end of the injector. This cartridge usually serves as a receiving chamber for storing and transporting the lens. After the cartridge has been placed on the handpiece of the injector body, the lens is pushed through the tapered channel to the outlet end by means of an axial displacement by means of a plunger, as a result of which the lens is folded or is still refolded. These known injectors are of relatively complex construction, made up of many individual parts, and the user has to assemble at least two separate parts before the lens can be pushed out.

An injector is known from WO 97/13476, in which the lens is previously folded in a folding instrument and then inserted radially into the injector together with the latter. Then the folded lens is removed from the Folding device pushed through the tapered application envelope, whereby the lens undergoes an even further folding. Two instruments are therefore necessary here, one for prefolding and one for injecting the folded lens.

An injector is known from WO 98/05281, the cartridge holding the lens at its rear end has a radially pivotable flap with a central holding rib, via which the unfolded lens is pressed radially into the transport channel and held there. However, the lens is really folded only when the lens is pushed forward through the tapered transport channel. There is therefore a relatively complex structure with correspondingly complex handling.

Finally, DE 43 03 051 AI shows an injector in which an unfolded lens is inserted via a radial input opening into the transport channel which is open radially upwards in this section, specifically on a lens holding carriage. The lens is held against falling out by a lens locking rod, which is pushed axially over the inserted lens. When pushing out, the support rod and slide are pushed together through a transport channel of the insertion tube which tapers at least at the beginning, as a result of which the lens, still held in the center by the support rod, is folded around this rod. Here too there is a relatively complex structure and in connection with it a relatively complex handling. In addition, the lens must be held in its position on the slide while being pushed by the locking rod. so as not to be pushed off the sled by the bar.

The object of the invention is to provide an injector which has the simplest possible structure and allows safe, sterile handling during storage, transport, folding and implantation, as well as a method for the folded deployment of the lenses and a packaging container for the injector.

This object is achieved by an injector with the features of claim 1.

Accordingly, the transport channel of the one-piece injector body is an axially continuous opening with a constant cross section. The transport channel is thus provided with the same cross-section throughout the entire injector, that is to say from the slide entry end to the lens ejecting end, which simplifies manufacture. In addition, the contact surface for the unfolded lens is arranged offset radially upward in the direction of insertion to the transport channel. As a result, the lens is introduced above the transport channel or at least substantially at a distance from the bottom of the transport channel, but at the same time it lies below the upper surface of the body. Finally, the holding rib or rod holding the unfolded lens on the support surface is a radially protruding, plate-shaped folding rib which is arranged in the manner of an embossing tool stamp and can be pressed radially or transversely to the transport direction through the slot-shaped insertion opening far into the transport channel. Folding rib and body thus act like Appropriately designed die and patrix on the intermediate lens and bend it in the middle, at the same time pushing it into the transport channel in the fully folded state. The lens then only needs to be pushed forward in the fully folded state in the transport channel by the slide, which is of course also a rod of constant cross section here.

In one development of the inventive idea, the one-piece injector body can have a rectangular cross-section overall, i.e. Both the thicker insertion and folding part as well as the thinner insertion part and also the transport channel each have a rectangular cross section. All of these parts, namely body sections and transport channel, can also have a round or oval cross section, or the holding part can be rectangular, while the insertion tube and transport channel have a round cross section.

Of course, the cross section of the transport channel must be designed in accordance with the dimensions of the folded lens. For example, the channel width must be approximately equal to twice the lens thickness plus folding rib thickness, while the channel height should be designed to be at least equal to half the lens diameter. The width of the folding rib in relation to the surfaces surrounding it, such as transport channel walls, is also designed so that the lens haptics are not pinched and damaged during folding and displacement.

Since the dimensions of the injector are relatively small overall, its components are partially interlocking during operation, which is due to the maximum it is possible to multiply the components. After folding the lens by pressing the folding rib into the transport channel, the folding rib remains in the pressed-in state in this way, even while the folded lens is being pushed out, preferably locked in position. For this reason, the push rod, which is constant in cross section, has a longitudinal groove on its upper side, which engages around the folding rib in a U-shaped manner during the longitudinal displacement with a slight sliding tolerance. It is also advantageous if the front side of the slide is designed to match the shape of the folded lens, that is to say an approximately quarter-cylinder inward curve, as a result of which a uniform sliding pressure is exerted on the lens.

In order to ensure safe handling of the injector in its roles as a lens holder, as a lens folding and as a lens insertion device, locking or indexing measures are provided on the slide, folding flap and body for the four different working end positions.

For example, three positions are provided for the slide, with corresponding positioning precautions, etc. a first position for setting the slide positions in the position retracted behind the radial input opening, a second advanced position in which the folded lens is pushed close to the front discharge opening of the insertion tube and finally a third and last position with up to the outlet opening of the Slider end face reaching insertion tube. The first two positions can be realized by means of indexing balls or knobs or the like, while the third position can also be achieved by striking the pressure plate provided on the outer end of the slide which protrudes from the injector body Injector body can be realized.

According to the invention, the preferably round contact surface for the unfolded lens is separated into two partial areas by the insertion and folding slit, which are horizontal, i.e. is aligned parallel to the bottom of the transport channel and at the same time to the top of the injector body. These partial contact surfaces can, however, also be inclined in a roof shape inwards in the direction of the transport channel, preferably at an angle of 30 ° to the horizontal or to the top of the body, or at an inclination which approximately corresponds to the inclination of the lens body. This and the additional large transition radii between the contact surface parts and the folding slit enable an optimal folding movement.

It is advantageous if narrow narrow support strips are provided just above the support surface, via which the lens is inserted onto the support surface with a slight snap and which also serve as support strips for the stop strips provided on the folding rib or on the corresponding folding lever. Thus, at least a slight holding of the lenses is realized by these support strips.

The folding rib, which can be pivoted radially through the insertion opening into and out of the transport channel, is provided at the front end of a folding lever which is pivotably articulated on the upper side of the body. In this case, a correspondingly wide groove can be provided on the upper side of the body holding part, in which the folding lever is completely recessed in the pivoted-in or folded-in state without protruding from the surface. But then around To enable the folding lever to be folded out again, a pressure plate provided over the folding rib on the lever, which occupies the entire width of the body, or other precautions must be possible to grip the recessed lever. However, the lever can also be articulated flat on the body via corresponding articulated ears on the body. These articulated ears of the body can be opened in a known manner upwards through a narrow slot, as a result of which the articulated pins can be pressed into the bearing openings via these slots. Such a snap assembly of the hinge can also be provided in the embodiment of the lever embedded in the body.

In order to determine the two working positions of the folding rib by means of the lever of the folding rib which can be folded over by approximately 180 °, corresponding indexing devices are provided on the lever and body, by means of which a lever angle position is fixed when the unfolded lens is held on the surface and when the folded lens is pressed in . This prevents the lever from pivoting upwards in the holding or folding position or from exerting too little pressure further, so that the lens falls out or shifts, so that it is not ensured that it is pushed out correctly.

According to a further development of the inventive concept, a transversely protruding handle plate is attached approximately in the middle to both sides of the body holding part in order to facilitate handling and also to fix the injector in a transport container as described below. In this way, in particular when the folded lens is ultimately brought out of the injector or when this lens is introduced into the eye, the The injector in approximately the same way as a hypodermic syringe.

It is particularly advantageous if the injector, which consists of only three parts, i.e. the injector body, slide and flap, is made entirely of transparent plastic, e.g. by injection molding, etc. so that the 3 injector components are put together or held together by simply pushing one into the other. Apart from the fact that the transparent position of the injector allows the respective position of the lens to be tracked exactly. For example, can be observed how the unfolded lens lies, how it is then folded over the folding rib by pushing it into the transport channel and then pushed forward and then pushed out via the slide. Any incorrect positions of the lens can be observed immediately, so that the person handling the injector can adjust to this situation in his further work.

Of course, the injector body can be formed in two parts for manufacturing reasons, with a parting plane parallel to the transport channel. After e.g. The two parts of the body are ready for injection molding and glued together.

According to the invention, the slide can also be formed in two parts, it being composed of a front, longitudinally displaceable part and a rear, rotatable part. The rear part has a thread which is guided in a threaded bore in the holding part in order to ensure a precisely controllable advance of the slide and thus of the lens. Known means such as opening and snap bolts - In addition, the common retraction of the entire slide can be achieved through the adjoining end faces of the slide parts.

The object of the invention is further achieved by a container for receiving, i.e. solved for storing and transporting an injector according to the invention. This consists essentially of a sleeve with a lid, in the inside of which lateral holding plates are provided for positioning the injector whose lateral grip plates. The holding plates each have a barb pointing in the direction of insertion, which grips around the injector handle plates and holds the injector against the inner wall of the container. By means of an axial mandrel on the cover, which is in contact with the rear end face of the injector body when the cover is in place, or by means of a spacer slit tube applied between the rear end face of the injector body and the rear pressure plate of the slide, and also the contact of the rear end face of the slide pressure plate on the inner end face of the Lid, which can be covered with very soft elastic plastic, optimal positioning of the injector is achieved in the container. Thus, even if the container is handled carelessly, the slide cannot be inadvertently pushed forward over its rear, retracted latching position in the transport channel, as a result of which the unfolded lens lying on the contact surface could be pushed off and ejected or even damaged.

According to the invention, the transport container or at least its receiving sleeve can likewise be made of transparent plastic in a manner known per se, for example by injection molding or blowing technology be made, which makes it easy to determine whether the injector - and thus the lens - are also in the correct position.

The transport container with the injector located therein can be filled with a sterile transport liquid known for the storage and delivery of folding lenses. After the injector has been inserted, the container sleeve is filled with the liquid in a vertical, open position. When the lid is put on, the lid mandrel and / or the inner lid cone displaces liquid, so that no air remains in the closed container, thereby ensuring sterile storage of the injector which maintains the lens elasticity.

The transport container can - as is generally the case with medicines and medical instruments - in turn be inserted in a packaging box in which an instruction leaflet is also inserted, thereby ensuring additional protection for the transport container and thus the injector and finally the lens itself.

Finally, the object is also achieved by a method for the folded delivery of an intraocular lens by the injector according to the invention. In this case, the folding lever that hides the radial insertion opening in the injector body is folded back by approximately 180 °, exposing the insertion opening, after which an unfolded lens is inserted or placed in the support surface provided at the upper end of the insertion opening. Then the folding lever is pivoted back again by approximately 180 ° until it lies with the underside of its folding rib on the The top of the lens body stands up, if possible by snapping the lever into this holding position. In this state, the "loaded" injector is then put into use or inserted into a transport container and fixed and stored for later use by being placed in a packaging box, etc. or made available for transport to other places of use.

When the device is used during an implantation operation, the folding lever on the injector, which may have been removed from a container beforehand, e.g. pressed radially up to the stop by pressing on its pressure plate with the folding rib underneath, whereby the folding rib presses the lens underneath from the support surface through the folding slot into the transport channel. At the same time, the lens lies or folds elastically around the folding rib in a longitudinally symmetrical manner and is thus brought into the folded insertion state. The slide is then moved from its reset rest position to the second position, which brings the lens into its position near the ejection opening in the transport channel. So the injector is ready for implantation of the folded lens inside it.

After the short surgical incision has been made on the eye and the narrow insertion tube part of the injector, the tip of which should be tapered for easier insertion, into the inside of the eye until it is inserted through the iris just above the lens bag, the injector slide is pushed further inwards to the end stop, whereby the lens is pushed out of the injector tip into the lens bag. The injector is then returned pulled and either thrown away as a disposable part or kept as a reusable part for refitting with an unfolded lens.

The invention is described in more detail below on the basis of several exemplary embodiments with reference to the drawing.

Show it:

1: a side view of an injector according to the invention in the first embodiment, with an inserted, unfolded lens and an overlying holding flap,

2: a side view as in FIG. 1, with the flap pressed in and the lens folded as a result,

3: a top view of an injector according to FIGS. 1 and 2,

4 shows a section III-III from FIG. 2, showing the arrangement of the individual parts to one another more clearly,

5: an end view according to arrow V from FIG. 1,

6: a side view of an injector body in the second embodiment, with a rectangular body holding part and a round insertion tube, transport channel and slide,

7: an end view according to arrow VII from FIG. 6,

8: a section VIII-VIII from FIG. 6, 9: a top view of the injector body according to FIG. 6,

10: a side view of a folding lever with folding ribs, for use in connection with the injector body according to FIGS. 5-8,

11: a plan view of the folding lever according to FIG. 10,

12: a side view of a slide for use in connection with the injector body according to FIGS. 6 to 9,

13: a front view of the slide according to FIG. 12,

14: a top view of the slide according to FIGS. 12 and

13, showing the groove for sliding along the folding rib,

15: a side view on a scale of 1: 1 on an injector according to FIGS. 6 to 14,

FIG. 16: a vertical section XVI-XVI from FIG. 15, with the folding lever pressed in, in a slightly modified form of lever and contact surface.

17: a longitudinal section through an injector packed in the transport container and packaging carton,

Fig. 18: an end view with the bottom of the container and box removed.

As can be seen in particular from FIG. 1, there is an Injector 1 according to the invention, in principle, from a body 2 to which a flap 3 is pivotably articulated and in which a slide 4 is arranged so that it can be moved slowly. The injector thus consists of only three simple components and is therefore easy to manufacture and handle.

The one-piece body 2 consists of a thicker insertion and holding part 5 and a much thinner insertion tube 6 and has a continuous transport channel 7 with a constant cross section. Both body parts have a rectangular cross section, as can be seen from FIG. 2. The front end of the insertion tube 6 with the discharge opening 8 is formed perpendicular to the longitudinal axis of the injector. On both sides of the body holding part 5, a grip plate 9 is fastened laterally so that the injector can be handled like an injection syringe, particularly when the lens is inserted into the eye. In addition, these grip plates serve to fix the injector in a transport container, which is described in more detail below with the aid of further figures.

As can be seen from FIGS. 1 to 4, the flap 3 consists of a lever 10 which has a plate-shaped folding rib 11 which projects downward on the underside of its front end. The flap lever 10 is pivotally mounted at its other end via laterally projecting stub axles 12, which can also be seen in FIG. 5, on the upper side of the body holding part 2 in corresponding bearing bores 13. These bearing holes 13 are open at the top through a snap slot 14, so that the stub axle 12 through the snap slot 14 only in for mounting the flap 3 on the body 1 the bearing holes 13 must be pressed. 5, the flap 3 is equipped at its front end with a wider pressure plate 15, on the underside of which the folding rib 11 is provided. As can also be seen from FIG. 1, the lens 20, which is still unfolded here, is held or arranged lying in the upper zone of the transport channel 7 on a support surface 16 shown in FIG. 4 and is held by the underside of the folding rib 11 against accidental falling out .

In Fig. 2, the flap 3 is shown in the pressed state, and it can be seen that in this state the lens 20 is folded in half in the transport channel 7 as a whole. The end face 17 of the plunger 4 is located behind the lens when viewed in the discharge direction and, by longitudinally displacing it, can push the lens forward in the direction of the outlet opening 8 in the transport channel 7.

5 shows the rectangular embodiment of the injector body, with holding part 5, insertion tube 6 and transport channel 7. Also there are the two handle plates 9, which here are rounded to the side in an approximately quarter-circle shape, in adaptation to the shape of the inner wall of the round transport container described in more detail below. If a rectangular transport container is used, the handle plates are of course also rectangular. The rectangular shape of the body holding part 5 can be clearly seen in FIG. 4, which shows the pressing situation of the flap from FIG. 3 in more detail. In this holding part 5 there is a rectangular slot, which at the same time - at least with regard to its underside - is part of the transport channel 7 in which the slider 4 is slidably inserted. At the top of the holding part 5, an insertion opening 18 is provided, which must have at least the dimensions of the lens 20 in length and width and can be round, as can be seen from FIG. 5. In the embodiment shown in FIG. 4, a support strip is provided on both sides of the insertion opening 18, on which the pressure plate 15 is finally supported in its downward folding movement. The strips 19 also serve at the same time to hold the lens in a coarse position, which when inserted over these strips snap into contact with the bearing surface 16.

FIG. 4 also shows how the lens 20 is placed elastically around the folding rib 11 in the folded state and is held pressed in in the transport channel 7. It can be seen that the bearing surface 16, which is interrupted in two parts by the upwardly open slot-shaped transport channel 7, merges into the side walls of the transport channel via large radii 21. In addition, the two parts of the support surface 16 are inclined to the horizontal by an angle 22 of approximately 30 ° and at the same time in the direction of the transport channel floor, as a result of which the foldable insertion movement of the lens is considerably facilitated. It can also be seen that the holding part 5 works through its support surface parts and transport channel slot in the manner of a die and the flap with the folding rib in the manner of a patrix of a bending or deep-drawing tool.

6 to 14, the three individual parts of an injector in the second embodiment are shown individually in detail.

6 to 9 show an injector body, the holding part 5, as in the previous example according to FIGS. 1 to 5, is rectangular, while its insertion tube 6 and the transport channel 7 have a round cross section. Furthermore, the arrangement of the bearing bores 13 and two indexing points, etc., can be seen in this view. a first indexing point 24 for fixing the flap with the folding rib resting on the unfolded lens and a second indexing point 25 for fixing the position of the flap in the fully pressed-in state with the lens folded in, pushed in vertically. In addition, it can be seen in particular from FIG. 6 that the front end face of the insertion tube 6 is arranged obliquely with the discharge opening 8, so that a front insertion tip 26 is formed which considerably facilitates insertion of this injector part by the small cut into the inside of the eye.

From Fig. 8 to 11 it can be seen that the flap lever is designed wide and in the pressed state is completely sunk into the surface of the holding part 5.

The indexing points 24 and 25 can also be seen on both sides, although only the arrangement of indexing points on one side can suffice.

10 and 11 the design of the flap can be seen, with a wide lever 10 and a narrow folding rib 11, which is fastened here directly to the lever 10, without a pressure plate located above it. Here too, the arrangement of the bearing stub axles 12, which are designed here as knobs, and of the two indexing points 24 and 25, which are likewise provided in the form of knobs on both sides of the lever, can be seen. 12 to 14 show a slide which in this embodiment has a round cross section and has a pressure plate on its outer side. At the top of the slider 4, a longitudinal groove 28 is introduced, the width of which is designed to correspond to the width of the folding rib, so that the slider is still slightly slowly displaceable despite the folding rib pressed into the transport channel. In addition, an inward curve is provided on the front end face of the slide 4, following a quarter circle, as a result of which there is an adaptation to the shape of the folded lens to be displaced. It can also be seen that there are three position devices on the slide, namely first position knobs 33 for the retracted slide position, second position knobs 34 for the advanced lens position and third position as an end stop 35 for the position in which the lens is off the injector is pushed out completely.

FIG. 15 shows an injector 30 according to the invention on an approximate scale of 1: 1, specifically in the second embodiment according to FIGS. 6 to 14. It can be seen that the extremely simple and only three-part construction of the injector 30 does quite delicate execution is effortlessly realizable.

Furthermore, FIG. 16 shows a section XVI-XVI from FIG. 15, similar to the illustration according to FIG. 4, with the flap 3 pressed in. Here, the lever 10 of the flap 3 is designed as a continuous flat part, on the lower front side of which the folding rib 11 is arranged. The underside of the lever 10 also serves as an indentation depth stop, in particular Effect with the contact surface 16 for the unfolded lens. The transport channel 7 is round and the insertion opening opens here tangentially into the round transport channel 7 via a folding and insertion slot 31 with vertical walls 32.

17 and 18, a packaged injector 1, 30 is shown. An injector 1, 30 according to the invention is placed in a transport container 40, which in turn is located in a packaging box 41 in which an instruction leaflet 42 is also packed.

It can be seen that the transport container 40 consists of a sleeve 39 which is closed by a cover 38. Here, a sleeve 39 with a round cross section is provided. However, it can also have a rectangular cross section.

In the interior of the sleeve 39, two plates 34 are arranged which are spaced apart from one another and are spaced apart from one another in such a way that the holding part 5 of the body can be easily inserted between them. The holding plates 43 serve as a longitudinal insertion stop for the injector, which is in contact with its handle plates 9 in the insertion direction. The holding plates 43 have hooks 44 on their free upper side which point in the direction of insertion and which grip around the upper side of the handle plates 9 and thus hold the injector against the wall of the sleeve 39. In addition, an axially pointing mandrel 37 is provided on the cover 38, which is in contact with the rear end of the body holding part of the injector, as a result of which the body is clamped between the holding plates 43 and mandrel 37 after the cover has been closed. Incorrect handling and possible dropping of the transport container can also result in the slider being pressed in unintentionally and thus ejecting the unfolded lens from the injector can be avoided.

Instead of the dome 37 provided on the cover 38, however, a spacer clip (not shown in the drawing) can also be used. This has a length equal to the distance between the rear end face of the holding part and the pressure plate of the slide in the retracted first slide position. It can be a slotted tube that can be easily pushed and pushed across the push rod. In addition, the outer end face of the slide pressure plate is then supported on the inside of the cover, which is advantageous if this inside is designed with a very soft material such as foam.

B E Z U G S Z E I C H E N L I S T E

1st injector, first version 29th tail

2. body 30. injector, second version

3rd flap 31st slot

4. Slider 32. walls

5. Holding part 33. First position knobs

6. Insertion tube 34. Second position knobs

7. Transport channel 35. End stop

8.Discharge opening 36 .--

Handle plate 37

10. Lever 38. Blanket

11. Folding rib 39. Sleeve

12. Axle stub 40. Transport container

13. Bearing pin 41. Carton

14. Snap slot 42. Package insert

15. Pressure plate 43. Holding plates

16. Support surface 44. Hook

17. Face

18. Feed opening

19. Support bar

20.Lentil

21. Radius

22. Inclination

23rd

24. First index point

25. Second index point

26. Insertion slot

27. Pressure plate

28. Longitudinal groove

Claims

PATENT TO SPEECH

1. Injector for implanting / inserting a (temporarily) folded intraocular lens, with which the folded lens can be inserted into the lens capsule of the eye through an approx. 3 mm cut opening in the eye

a body which consists of a thicker insertion and holding part and a thinner insertion tube on the insertion side and has an axial through opening as a transport channel,

- A slide, which is arranged axially displaceably in the transport channel, and

- A radial insertion opening provided in the insertion and holding part transversely to the axis of the transport channel as an insertion channel for the lens, which is connected to the transport passage opening, and in which the unfolded lens for transport lies flat on a support surface and via a longitudinal center holding rib extending to the lens is held, characterized in that

- That the body (2) is formed in one piece,

- That the transport channel (7) is a continuous opening with a constant cross-section,

- That the support surface (16) is arranged offset in the radial direction with respect to the axis of the transport channel (7),

- And that the retaining rib is a flattenföπnig radially extending folding rib (11) which can be pushed radially through the insertion opening (18) into the transport channel (7), such that the lens folded around the retaining rib is completely inserted into the transport channel.

2. Injector according to claim 1, characterized in that the injector body (5) has a rectangular cross-section overall and that the transport channel (7) is rectangular.

3. Injector according to claim 2, characterized in that the transport channel (7) has a width approximately equal to twice the lens thickness plus folding rib thickness and a height approximately equal to half the lens diameter.

4. Injector according to claim 1, characterized in that the slide (4) is a rod of the same cross-section throughout, on the top of which a groove (28) with a width slightly larger than the width of the folding rib (11), for displacement when the folding rib is pressed in , is provided, and that the slide end face has an approximately quarter-cylinder curve (29) inwards, adapted to the edge of the folded lens (20).

5. Injector according to claim 4, characterized in that three positioning devices are provided on the slide (4) and body (2, 5) in the longitudinal or sliding direction, specifically for a first, retracted slide position (33), with lenses released -Input opening, for a second position (34), with the lens pushed forward near the front discharge opening and for a third end stop position (35) with from the injector (1, 30) fully extended lens (20).

6. Injector according to claim 1, characterized in that the support surface (16) for the unfolded lens (20) consists of two partial surfaces separated by a longitudinal slot (31), which are inclined roof-shaped inwards in the direction of the transport channel (7), preferably at an angle of approximately 30 ° to the horizontal and over large radii (21) into the side walls (32) of the transport channel or slot.

7. Injector according to claim 6, characterized in that on both longitudinal sides of the input opening (18), above the support surfaces (16), support strips (19) for stop strips of the folding rib (11) are provided.

8. Injector according to claim 1, characterized in that the folding rib (11) is provided at the front end of a pivotally hinged folding lever (3, 10) on the top of the body.

9. Injector according to claim 8, characterized in that on the lever (3, 10) of the folding rib (11) which can be folded over by approximately 180 °, two indexing devices (24, 25) known per se are provided, such as balls, knobs or the like, in connection with corresponding precautions on the body, for determining the lever angle position when the holding the unfolded lens and holding the folded lens in.

10. Injector according to claim 9, characterized in that the lever (10) at the level of the folding rib (11) is broadened to approximately body width to form a pressure plate (15) which, in the pressed-in folded state, on the support surface (16) or the support strips ( 19) itself and at the same time the folding rib (11) is supported radially.

11. Injector according to claim 1, characterized in that on both sides of the body-holding part (5) each has a transversely projecting handle plate (9) in the middle.

12. Injector according to claim 1, characterized in that the injector body (2) has a round cross-section overall, with a round transport channel and round slide rod and that the radial input and folding slot (31) between the lens support surface (16) and transport channel (7th ) has longitudinal walls (32) running tangentially to the transport channel wall.

13. Injector according to claims 1 to 12, characterized in that all three components of the injector, namely body (2), flap (3) and slide (4), made of transparent plastic, for example by injection molding are and that the three injector parts are assembled by simply pushing and pushing each other and are held together by snap knobs or snap joints.

14. Container for storing and transporting an injector according to claims 1 to 13, characterized in that the transport container (49) consists of a sleeve (39) with a lid (38) in the side holding plates (43) for holding the injector ( 1, 30) are provided over the handle plates (9).

15. A container according to claim 14, characterized in that the holding plates (43) are provided with snap hooks (44) for gripping behind the grip plates (9).

16. A container according to claim 14, characterized in that the cover (38) is provided with a fixing mandrel (37) projecting axially into the interior of the container in the assembled state and pending against the rear end face of the injector body.

17. A container according to claims 14 to 16, characterized in that at least the sleeve (39) is made of transparent plastic, preferably by injection molding or by blowing technology.

18. A method for folded delivery of an intraocular lens by an injector according to claims 1 to 13, characterized by the following steps:

Folding back the injector folding lever (3, 10), thereby exposing the radial insertion opening (18) of the body (5),

- inserting the unfolded lens into the support surface (16) provided on the input side at the insertion opening (18),

- Folding back or swiveling the folding lever (3) to rest with its folding rib (11) on the top of the body of the unfolded lens (20), preferably latching in this position,

- Firm, radial pressing on the pressure plate (15) or the top of the folding rib (11) of the folding lever (3), whereby the lens is pushed radially down into the transport channel (7) and at the same time folded around the folding rib (11) ,

- axial displacement of the folded lens located in the transport channel by longitudinally displacing the slide (4) from its first, retracted position into the second, advanced position of the lens near the outlet opening,

- Complete pushing out of the folded lens, after the insertion of the insertion tube (6) of the injector into the eye through the cut, by moving the slide from the second position to the third end stop position, and

- then withdrawing the injector or the injector tip from the eye and possibly recharging the injector with a new, unfolded lens.